Trial Outcomes & Findings for PuraBond® and Pain Following Resection of Oral or Oropharyngeal Mucosal Lesions (NCT NCT05773781)

Results Overview

Visual Analogue Scale (VAS) score from 0 (no pain) to 10 (worst pain)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

73 participants

Primary outcome timeframe

Baseline and day 4

Results posted on

2025-09-16

Participant Flow

Participant milestones

Participant milestones
Measure	PuraBond® Surgery with PuraBond® application to surgical field.	No PuraBond® Surgery without PuraBond® application to surgical field.
Overall Study STARTED	36	37
Overall Study COMPLETED	32	36
Overall Study NOT COMPLETED	4	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PuraBond® n=32 Participants Surgery with PuraBond® application to surgical field.	No PuraBond® n=36 Participants Surgery without PuraBond® application to surgical field.	Total n=68 Participants Total of all reporting groups
Age, Continuous	64 years n=32 Participants	64 years n=36 Participants	64 years n=68 Participants
Sex: Female, Male Female	6 Participants n=32 Participants	11 Participants n=36 Participants	17 Participants n=68 Participants
Sex: Female, Male Male	26 Participants n=32 Participants	25 Participants n=36 Participants	51 Participants n=68 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United Kingdom	32 participants n=32 Participants	36 participants n=36 Participants	68 participants n=68 Participants
Smoking status Never	14 Participants n=32 Participants	21 Participants n=36 Participants	35 Participants n=68 Participants
Smoking status Ex-smoker	12 Participants n=32 Participants	12 Participants n=36 Participants	24 Participants n=68 Participants
Smoking status Current	6 Participants n=32 Participants	3 Participants n=36 Participants	9 Participants n=68 Participants
Primary tumour site Oral cavity	9 Participants n=32 Participants	12 Participants n=36 Participants	21 Participants n=68 Participants
Primary tumour site Oropharynx	23 Participants n=32 Participants	24 Participants n=36 Participants	47 Participants n=68 Participants

PRIMARY outcome

Timeframe: Baseline and day 7

Visual Analogue Scale (VAS) score from 0 (no pain) to 10 (worst pain)

Outcome measures

Outcome measures
Measure	PuraBond® n=31 Participants Surgery with PuraBond® application to surgical field.	No PuraBond® n=33 Participants Surgery without PuraBond® application to surgical field.
Change From Baseline in Cumulative Pain on the Visual Analogue Scale (VAS) at Postoperative Week 1	3.27 score on a scale Standard Deviation 2.75	4.35 score on a scale Standard Deviation 2.90

PRIMARY outcome

Timeframe: Baseline and day 14

Visual Analogue Scale (VAS) score from 0 (no pain) to 10 (worst pain)

Outcome measures

Outcome measures
Measure	PuraBond® n=31 Participants Surgery with PuraBond® application to surgical field.	No PuraBond® n=33 Participants Surgery without PuraBond® application to surgical field.
Change From Baseline in Cumulative Pain on the Visual Analogue Scale (VAS) at Postoperative Week 2	2.95 score on a scale Standard Deviation 2.67	3.91 score on a scale Standard Deviation 2.91

PRIMARY outcome

Timeframe: Baseline and day 30

Visual Analogue Scale (VAS) score from 0 (no pain) to 10 (worst pain)

Outcome measures

Outcome measures
Measure	PuraBond® n=31 Participants Surgery with PuraBond® application to surgical field.	No PuraBond® n=33 Participants Surgery without PuraBond® application to surgical field.
Change From Baseline in Cumulative Pain on the Visual Analogue Scale (VAS) at Postoperative Day 30	2.56 score on a scale Standard Deviation 2.63	3.41 score on a scale Standard Deviation 2.99

PRIMARY outcome

Timeframe: Baseline and day 1

Visual Analogue Scale (VAS) score from 0 (no pain) to 10 (worst pain)

Outcome measures

Outcome measures
Measure	PuraBond® n=31 Participants Surgery with PuraBond® application to surgical field.	No PuraBond® n=33 Participants Surgery without PuraBond® application to surgical field.
Change From Baseline in Pain on the Visual Analogue Scale (VAS) at Day 1	2.46 score on a scale Standard Deviation 2.97	3.30 score on a scale Standard Deviation 3.06

PRIMARY outcome

Timeframe: Baseline and day 2

Visual Analogue Scale (VAS) score from 0 (no pain) to 10 (worst pain)

Outcome measures

Outcome measures
Measure	PuraBond® n=31 Participants Surgery with PuraBond® application to surgical field.	No PuraBond® n=33 Participants Surgery without PuraBond® application to surgical field.
Change From Baseline in Pain on the Visual Analogue Scale (VAS) at Day 2	2.98 score on a scale Standard Deviation 2.79	3.87 score on a scale Standard Deviation 2.97

PRIMARY outcome

Timeframe: Baseline and day 4

Visual Analogue Scale (VAS) score from 0 (no pain) to 10 (worst pain)

Outcome measures

Outcome measures
Measure	PuraBond® n=31 Participants Surgery with PuraBond® application to surgical field.	No PuraBond® n=33 Participants Surgery without PuraBond® application to surgical field.
Change From Baseline in Pain on the Visual Analogue Scale (VAS) at Day 4	3.36 score on a scale Standard Deviation 2.53	4.06 score on a scale Standard Deviation 2.72

PRIMARY outcome

Timeframe: Baseline and day 7

Visual Analogue Scale (VAS) score from 0 (no pain) to 10 (worst pain)

Outcome measures

Outcome measures
Measure	PuraBond® n=31 Participants Surgery with PuraBond® application to surgical field.	No PuraBond® n=33 Participants Surgery without PuraBond® application to surgical field.
Change From Baseline in Pain on the Visual Analogue Scale (VAS) at Day 7	3.15 score on a scale Standard Deviation 2.61	4.28 score on a scale Standard Deviation 2.76

PRIMARY outcome

Timeframe: Baseline and day 14

Visual Analogue Scale (VAS) score from 0 (no pain) to 10 (worst pain)

Outcome measures

Outcome measures
Measure	PuraBond® n=31 Participants Surgery with PuraBond® application to surgical field.	No PuraBond® n=33 Participants Surgery without PuraBond® application to surgical field.
Change From Baseline in Pain on the Visual Analogue Scale (VAS) at Day 14	1.38 score on a scale Standard Deviation 1.55	1.66 score on a scale Standard Deviation 1.88

PRIMARY outcome

Timeframe: Baseline and day 30

Visual Analogue Scale (VAS) score from 0 (no pain) to 10 (worst pain)

Outcome measures

Outcome measures
Measure	PuraBond® n=30 Participants Surgery with PuraBond® application to surgical field.	No PuraBond® n=31 Participants Surgery without PuraBond® application to surgical field.
Change From Baseline in Pain on the Visual Analogue Scale (VAS) at Day 30	0.23 score on a scale Standard Deviation 0.65	0.26 score on a scale Standard Deviation 1.88

SECONDARY outcome

Timeframe: Within 30 days post operatively

Number of patients requiring hospital readmission

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Within 24 hours post operatively

Number of patients with primary haemorrhage

Outcome measures

Outcome measures
Measure	PuraBond® n=32 Participants Surgery with PuraBond® application to surgical field.	No PuraBond® n=36 Participants Surgery without PuraBond® application to surgical field.
Primary Haemorrhage	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 1 to day 30 post operatively

Number of patients with secondary haemorrhage

Outcome measures

Outcome measures
Measure	PuraBond® n=32 Participants Surgery with PuraBond® application to surgical field.	No PuraBond® n=36 Participants Surgery without PuraBond® application to surgical field.
Secondary Haemorrhage	2 Participants	6 Participants

SECONDARY outcome

Timeframe: Within 30 days post operatively

Length of stay in hospital

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 hours post operatively

Number of patients requiring return to operating room

Outcome measures

Outcome measures
Measure	PuraBond® n=32 Participants Surgery with PuraBond® application to surgical field.	No PuraBond® n=36 Participants Surgery without PuraBond® application to surgical field.
Primary Return to Theatre	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 1 to day 30 postoperatively

Number of patients requiring return to operating room

Outcome measures

Outcome measures
Measure	PuraBond® n=32 Participants Surgery with PuraBond® application to surgical field.	No PuraBond® n=36 Participants Surgery without PuraBond® application to surgical field.
Secondary Return to Theatre	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Within 30 days post operatively

Time taken to normal dietary intake

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Within 30 days post operatively

Drug, dose, route and frequency of post-operative analgesia usage

Outcome measures

Outcome data not reported

Adverse Events

PuraBond®

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

No PuraBond®

Serious events: 3 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	PuraBond® n=32 participants at risk Surgery with PuraBond® application to surgical field.	No PuraBond® n=36 participants at risk Surgery without PuraBond® application to surgical field.
Surgical and medical procedures Haemorrhage	0.00% 0/32 • 30 days	2.8% 1/36 • 30 days
Vascular disorders Cerebral infarct	0.00% 0/32 • 30 days	2.8% 1/36 • 30 days

Other adverse events

Other adverse events
Measure	PuraBond® n=32 participants at risk Surgery with PuraBond® application to surgical field.	No PuraBond® n=36 participants at risk Surgery without PuraBond® application to surgical field.
Injury, poisoning and procedural complications Haemorrhage	3.1% 1/32 • 30 days	11.1% 4/36 • 30 days
Infections and infestations Wound infection	6.2% 2/32 • 30 days	0.00% 0/36 • 30 days
Infections and infestations Chest infection	9.4% 3/32 • 30 days	2.8% 1/36 • 30 days
Renal and urinary disorders Urinary retention	0.00% 0/32 • 30 days	2.8% 1/36 • 30 days
Injury, poisoning and procedural complications First bite syndrome	0.00% 0/32 • 30 days	2.8% 1/36 • 30 days

Additional Information

Mr Jason Fleming

University of Liverpool

Phone: 0151 529 5259

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place